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Administrator
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Posted - 05/13/2005 :  15:21:09  Show Profile  Visit Administrator's Homepage  Reply with Quote  Reply to Topic
Flupenthixol is an antipsychotic medication that is licenced for the treatment of Schizophrenia. It is also effective for the acute treatment of mania and mixed episodes of Bipolar I Disorder. Its use for maintenance treatment of Bipolar I Disorder is controversial. Flupenthixol sometimes causes parkinsonian-like side-effects, but there is no evidence that it increases the risk of diabetes mellitus.
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Posted - 05/18/2007 :  11:46:01  Show Profile  Visit Administrator's Homepage  Reply with Quote  Reply to Topic
Dear Members,

The following important research studies can be found at PubMed:

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Search&db=PubMed&term=flupenthixol/therapeutic+use[MAJR]&dispmax=200

Note: Don't click on the above URL; instead copy and paste it into your browser's address box, then let your browser find this URL address.

Summary: Research has shown that flupenthixol is just as effective as an antipsychotic medication as risperidone, olanzapine, haloperidol, and fluphenazine decanoate. Unlike risperidone and olanzapine, flupenthixol does not cause significant weight gain.

Low dose flupenthixol has been shown to be an effective antidepressant medication. As such, it is the only depot antidepressant medication currently available (i.e., an injection lasts 14 days).


1: Psychiatr Prax. 2004 Nov;31 Suppl 1:S167-9.

[Incidence of rigor during treatment with flupentixol decanoate in comparison to risperidone]

[Article in German]

Scherer J, Dobmeier P, Kuhn K, Schmaus W.

Klinik des Bezirks Oberbayern am Klinikum Garmisch-Partenkirchen.
josef.scherer@psychiatrie-gap.de

STUDY OBJECTIVE: We investigated as to whether dosedependent extrapyramidal
tolerance of Flupentixol decanoate is inferior to that of Risperidone. METHOD:
143 Risperidone and 177 Flupentixol decanoate treated patients were
consecutively entered into this non - randomized open study and assessed with
the Simpson-Angus-Scale regarding presence of rigor. Treatment comparisons of
rigor frequency was done by Kaplan-Meier analysis. RESULTS: The risk of rigor
increased with dose on both treatments. EPMS-risk was not increased under
treatment with Flupentixol decanoate (mean dose 35.06 19.7 mg/2 weeks)
compared to Risperidone (mean daily dose: 5.2 2.5 mg/kg) when comparable
weight standardized Haloperidol equivalence doses (WHE) were used. CONCLUSION:
This study offers limited evidence for methodological reasons. Yet, results do
not support the view that EPS are more frequent on Flupentixol decanoate than on
Risperidone when doses are comparable.

Publication Types:
Clinical Trial
Comparative Study
English Abstract

PMID: 15570542 [PubMed - indexed for MEDLINE]

2: Pharmacopsychiatry. 2004 Nov;37(6):279-85.

Olanzapine versus flupenthixol in the treatment of inpatients with
schizophrenia: a randomized double-blind trial.


Gattaz WF, Diehl A, Geuppert MS, Hubrich P, Schmitt A, Linde I, Maras A,
Dittmann RW.

Department and Institute of Psychiatry, Laboratory of Neuroscience (LIM 27),
Faculty of Medicine, University of Sao Paulo, Rua Dr. Ovidio Pires de Campos
s/n, PO Box 3671, 05403-010 Sao Paulo, Brazil. gattaz@usp.br

OBJECTIVE: The atypical antipsychotic olanzapine has extensively been compared
with haloperidol, whereas studies vs. other (conventional) neuroleptics are
scarce. This exploratory double-blind 4-week study was designed to compare the
efficacy and the safety of olanzapine (OLA) and flupenthixol (FLU) which have
recently been considered as a "partially atypical" antipsychotics. METHODS:
Twenty-eight inpatients with schizophrenia (DSM-IV) were randomly assigned for
treatment with OLA (N = 15, 5-20 mg/d) or FLU (N = 13, 5-20 mg/d). The Brief
Psychiatric Rating Scale (BPRS) and the Negative Symptoms Rating Scale (NSRS),
plus the Patient Global Impression (PGI) and Clinical Global Impression (CGI)
scales, were used to assess the efficacy of both compounds; safety was
determined by using the Simpson Angus Scale (SAS) and the Abnormal Involuntary
Movement Scale (AIMS) and by assessing treatment-emergent adverse events.
Non-parametric statistics were applied. RESULTS: BPRS and NSRS scores improved
in both groups (exploratory tests; all p < or = 0.02). Similar results were
observed for CGI-Severity, CGI- and PGI-Improvement. There were no significant
group differences. Responder rates (at least 40 % decrease in BPRS total) were
9/13 OLA patients (69 %) and 9/12 FLU patients (75 %). EPS events were reported
only in the FLU group (p < 0.01); FLU patients needed significantly more
anticholinergic medication. Weight gain was higher in OLA patients (p < 0.01).
Overall, fewer patients with adverse events were observed in the OLA group (p =
0.04). No significant changes were noted on SAS and AIMS scores. CONCLUSION:
Findings from this study suggest that overall and negative symptomatology
improved in both treatment groups, while the safety and tolerability profiles
differed for both substances.

Publication Types:
Clinical Trial
Comparative Study
Randomized Controlled Trial

PMID: 15551194 [PubMed - indexed for MEDLINE]

3: Fortschr Neurol Psychiatr. 2004 Jul;72(7):397-403.

[Quality of life and therapeutic result in outpatients with schizophrenia under
flupenthixol treatment]


[Article in German]

Kuhn KU, Quednow BB, Landen H, Riedel M, Thiel M.

Universitat Bonn, Klinik fur Psychiatrie und Psychotherapie, Bonn.
k.u.kuehn@uni-bonn.de

The objective of this phase IV surveillance study was to document the efficacy
and tolerability of flupenthixol as well as the quality of life of patients
suffering from schizophrenia and to gain insights into which doses were actually
used in specialists outpatients care. The observational variables in this study
include demographic variables, details of the diagnosis as well as concomitant
diseases. Further evaluations included the assessment of CGI-Scale and
subjective patient quality of live assessment using a standardised
questionnaire. This questionnaire SWN-K (subjective well-being under neuroleptic
treatment; short version) includes 20 items on the state of health with a
six-point scale from "absolutely not" to "very strong" respectively. 66.3 %
Patients were treated with the depot form of flupenthixol, the rest with oral
medication with mean doses of 9.2 mg/d i. m. and 6.3 mg/d p. o. respectively.
78.8 % of patients improved on the CGI-Scale, 5.5 % had an adverse event and in
4.6 % of patients this event was related to the medication. 0.3 % of patients
had a serious adverse event. The mean of SWN-K improved from 61.2 to 78.5 in the
course of study. The CGI improved from 5.83 to 3.43 in the course of treatment.

Publication Types:
English Abstract

PMID: 15252753 [PubMed - indexed for MEDLINE]

4: Psychiatr Prax. 2003 May;30 Suppl 2:S94-6.

[Comparative effectiveness of flupenthixol and risperidone on negative symptoms
of schizophrenia]


[Article in German]

Philipp M, Lesch OM, Schmauss M, Dose M, Glaser T.

Bezirkskrankenhaus Landshut, Prof.-Buchner-Strasse 22, 84034 Landshut.

The efficacy of flupentixol and risperidone were compared in a randomized
double-blind study in 153 chronic schizophrenic patients. Flupentixol showed to
be not inferior to risperidone concerning schizophrenic negative symptoms at
week 8, 16 and 24. Positive symptoms and general psychopathology improved
comparably, too. There was a trend in favor of flupentixol concerning the
improvement of depressive symptoms and a trend in favor of risperidone
concerning the improvement of preexisting parkinsonian symptoms. The study data
justify to regard flupentixol as a "partial atypical" antipsychotic.

Publication Types:
Clinical Trial
Comparative Study
English Abstract
Multicenter Study
Randomized Controlled Trial

PMID: 14509050 [PubMed - indexed for MEDLINE]

5: Eur Addict Res. 2003 Apr;9(2):65-72.

Flupenthixol in relapse prevention in schizophrenics with comorbid alcoholism:
results from an open clinical study.


Soyka M, Aichmuller C, v Bardeleben U, Beneke M, Glaser T, Hornung-Knobel S,
Wegner U.

Psychiatric Hospital University of Munich, Munich, Germany.
Michael.Soyka@psy.med.uni-muenchen.de

Substance use, especially alcoholism, has been recognized as a significant
problem in schizophrenic patients, though only a few studies on the effects of
pharmacotherapy in these patients have been conducted so far. The thioxanthene
neuroleptic flupenthixol, which can be given intramuscularly (i.m.) for
improving compliance, has been studied as a possible anti-craving drug both in
animal models of alcoholism and some clinical studies. Pilot studies suggest
that comorbid schizophrenics with substance use may benefit from treatment with
flupenthixol. Efficacy of flupenthixol (10-60 mg i.m.) in reducing alcohol
consumption of dual diagnosis patients was studied in an open 6-month clinical
trial in 27 schizophrenics with comorbid alcoholism. Twenty-one patients entered
the intention-to-treat analysis. Fourteen subjects were completers, 13 dropped
out. Six patients completely abstained from alcohol during treatment. Alcohol
consumption was significantly reduced compared to baseline (4 weeks before
treatment as measured by timeline follow-back interview). In general, while
patients showed a marked improvement concerning alcohol consumption, only a
slight improvement in psychopathology was recorded. Overall tolerability was
good. These data indicate a probable beneficial effect of flupenthixol in
schizophrenic patients with comorbid alcoholism. Although the efficacy of
flupenthixol as an anti-craving drug in dual diagnosis patients has to be
explored in further studies, the drug may be considered a promising medication
for these patients. Copyright 2003 S. Karger AG, Basel

Publication Types:
Clinical Trial
Comparative Study
Evaluation Studies
Multicenter Study

PMID: 12644732 [PubMed - indexed for MEDLINE]

6: Neuropsychobiology. 2003;47(1):37-46.

Flupenthixol versus risperidone: subjective quality of life as an important
factor for compliance in chronic schizophrenic patients.


Hertling I, Philipp M, Dvorak A, Glaser T, Mast O, Beneke M, Ramskogler K,
Saletu-Zyhlarz G, Walter H, Lesch OM.

Department of Psychiatry, University of Vienna, Wahringer Gurtel 18-20, A-1090
Vienna, Austria.

OBJECTIVE: The primary aim of this paper was to compare the effects of
flupenthixol and risperidone on subjective quality of life and attitude towards
medication in chronic schizophrenic patients with mainly negative symptoms. In a
spectrum ranging from its typical end "haloperidol" to its atypical end
"clozapine", flupenthixol has typical and atypical characteristics. METHODS: The
effects of flupenthixol versus risperidone were investigated in a multicenter,
double-blind trial, whereas subjective quality of life was assessed by means of
the EuroQuol-Visual Analogue Scale and the patient satisfaction questionnaire.
The attitude towards medication was assessed by means of the Drug Attitude
Inventory-30 (DAI-30). RESULTS: Mean daily dose of study medication was 6.6 (SD
2.9) mg/day flupenthixol and 3.6 (SD 1.2) mg/day risperidone. Both groups showed
a significant improvement regarding subjective quality of life and positive
attitude towards medication. Especially the categories "control of their
thoughts", concentration and "feeling better in general" ameliorated in both
groups. In the flupenthixol group, the "ability to cope with stress", "feel more
relaxed" and the "ability to achieve something" improved significantly more than
in the risperidone group. CONCLUSIONS: (1) The spectrum of schizophrenia can be
treated effectively with different neuroleptic treatments. (2) Flupenthixol
especially improves the ability to cope with stress, the ability to achieve
something and feeling more relaxed. (3) Subjective quality of life significantly
increased with no difference between the groups. Copyright 2003 S. Karger AG,
Basel

Publication Types:
Clinical Trial
Multicenter Study
Randomized Controlled Trial

PMID: 12606844 [PubMed - indexed for MEDLINE]

7: Fortschr Neurol Psychiatr. 1998 Oct;66(10):442-9.

[Positive and negative symptoms in chronic schizophrenic patients under
maintenance therapy with flupenthixol decanoate for a twelve month perioid]


[Article in German]

Pach J, Finkbeiner T, Glaser T, Haug J, Osterheider M, Tegeler J.

Psychiatrische Klinik, Kliniken Essen-Mitte.

62 chronic schizophrenics, who after a psychotic exacerbation were stabilized
again, were randomized on 3 different maintenance dosages of
flupentixol-decanoate and observed for 12 months. 15 (24.2%) patients had a
relapse independently of the dose. 34 of the 47 patients without relapse had
complete documentations of the follow-up. After 3 to 6 months there was an
obvious and constant clinical improvement as assessed by various test
inventories. The BPRS-scores for psychopathology, negative and positive symptoms
improved significantly between 14 to 18%. There was also significant reduction
of negative symptoms assessed by SANS (22%) as well in the severity of illness
(CGI) and an amelioration of psychosocial functioning (GAS, Strauss-Carpenter).
At the end of trial 26.4% of the patients had mild involuntary movements (AIMS),
23.5% were on antiparkinson-medication. It is concluded that there could be an
indication for flupentixol-decanoate in the long term maintenance therapy
especially of chronic schizophrenics with negative symptoms and problems of
compliance under oral medication.

Publication Types:
Clinical Trial
English Abstract
Multicenter Study
Randomized Controlled Trial

PMID: 9825249 [PubMed - indexed for MEDLINE]

8: Eur Neuropsychopharmacol. 1997 Nov;7(4):261-6.

Tolerability of low dose neuroleptics: a case control study of flupenthixol.

Fritze J, Spreda I.

Klinik fur Psychiatrie und Psychotherapie I, Zentrum der Psychiatrie, Johann
Wolfgang Goethe-Universitat, Frankfurt am Main, Germany.

There are no data available on the risk of extrapyramidal symptoms when using
long-term flupenthixol in low dosage in patients suffering from anxiety and
depressive disorders. In a case control study 106 patients essentially treated
with the neuroleptic flupenthixol in a so-called low, non-antipsychotic dosage
were compared to n=37 otherwise comparable patients who never had been treated
with neuroleptics. The investigator was blind to the previous treatment
conditions. Extrapyramidal symptoms were found although with a low prevalence
and mild degree: 6.7% tardive dyskinesia, none in controls; pseudoparkinsonism
26%, 16% in controls. Extrapyramidal side-effects, especially tardive
dyskinesia, have to be considered in the individual weighing of therapeutic
benefits and risks even when prescribing flupenthixol in low dosages.

Publication Types:
Comparative Study

PMID: 9443657 [PubMed - indexed for MEDLINE]

9: Pharmacotherapy. 1991;11(6):450-9.

Antidepressant effects of flupenthixol.

Gruber AJ, Cole JO.

Affective Disease Program, McLean Hospital, Belmont, Massachusetts 02176.

Strong evidence exists that flupenthixol, not presently distributed in the
United States, is an effective antidepressant. Its advantages over available
antidepressants include its safety with respect to overdose and in combination
with other medications, low dependency risk, rapid onset of action, and
availability in depot preparation. Flupenthixol also may be useful as a mood
elevator for schizophrenics, an alternative mood stabilizer for patients with
bipolar disease, and a facilitator for cocaine withdrawal.

Publication Types:
Clinical Trial
Review

PMID: 1771144 [PubMed - indexed for MEDLINE]

10: Curr Med Res Opin. 1990;12(3):191-7.

Depression in general practice: a comparison of flupenthixol dihydrochloride and
dothiepin hydrochloride.


Dwivedi VS, Berger AB, Khong TK, Hamilton BA, Jones PG, Brantingham P, Grillage
MG, Prasad S, Kundu BN, Renwick JA, et al.

A single-blind, parallel group, general practice study was carried out in 153
patients with mild to moderate depression to compare the efficacy and
tolerability of flupenthixol dihydrochloride and dothiepin hydrochloride.
Patients were allocated at random to receive single daily doses of either 1 mg
flupenthixol in the morning or 75 mg dothiepin in the evening, and this dose
could be doubled at the end of 2 weeks in the event of inadequate response.
Assessments were made on entry and after 1, 2, 4 and 6 weeks of treatment using
the Hamilton Depression Rating Scale, a 4-point severity scale and an unwanted
symptoms checklist. The results showed that both treatments significantly
improved the patients' condition over 6 weeks, and there was a significant
difference in favour of flupenthixol at end-point. Both drugs were well
tolerated, although persistence of anticholinergic side-effects in the dothiepin
group resulted in a trend favouring flupenthixol. One patient in the
flupenthixol group attempted suicide by overdose but made a complete recovery.

Publication Types:
Clinical Trial
Comparative Study
Randomized Controlled Trial

PMID: 2272193 [PubMed - indexed for MEDLINE]

11: Curr Med Res Opin. 1990;12(1):51-7.

A double-blind comparison of oral amitriptyline and low-dose intramuscular
flupenthixol decanoate in depressive illness.


Maragakis BP.

Department of Psychological Medicine, Billinge Hospital, Wigan, England.

Fifty-seven hospital out-patients with depressive symptoms were studied in a
double-blind manner for up to 4 weeks, 30 whilst being treated with
intramuscular flupenthixol decanoate (5 to 10 mg/fortnight) and 27 with oral
amitriptyline (75 to 150 mg/day). The results of assessment using the Hamilton
Rating Scale for Depression, the Leeds Self-Rating Scale for Depression and the
Clinical Global Impressions severity scale showed that both therapies were
effective in resolving depression in the patients studied. The two treatments
were well tolerated and side-effect profiles were similar, dry mouth,
faintness/dizziness and drowsiness being the most frequently reported adverse
events. Extrapyramidal signs were seen in similar numbers of patients in each
treatment group. One patient from each of the two groups was withdrawn from
therapy before the end of the study because of adverse events.

Publication Types:
Clinical Trial
Comparative Study
Randomized Controlled Trial

PMID: 2188797 [PubMed - indexed for MEDLINE]

12: Curr Med Res Opin. 1989;11(9):593-9.

Primary care treatment of depression in the elderly: a double-blind,
multi-centre study of flupenthixol ('Fluanxol') and sustained-release
amitriptyline.


Hostmaelingen HJ, Asskilt O, Austad SG, Fjellheim J, Hostmaelingen EA,
Kristiansen PH, Olsen TI, Skotte T, Ofsti E.

A multi-centre general practice study was carried out to compare flupenthixol
and a sustained-release preparation of amitriptyline in the primary care
treatment of depression in the elderly. Fifty-one clinically depressed patients,
aged 65 years or over, were allocated at random to one of the two treatment
groups in this 4-week double-blind, double-dummy study. On entry, patients
received either a 0.5 mg flupenthixol tablet in the morning and a placebo
capsule at night (25 patients) or a 25 mg sustained-release amitriptyline
capsule at night and a placebo tablet in the morning (26 patients), but at the
end of the first or second weeks the dosage could be doubled according to the
assessed clinical need. Fourteen patients in each treatment group had their
dosages doubled. Patient assessment was undertaken on study entry and after 1, 2
and 4 weeks of treatment using a 0 to 3 scale global assessment and the
Montgomery Asberg Depression Rating Scale; side-effects were recorded on the UKU
Scale. After 4-weeks' treatment, over 80% of patients in each group had improved
and in the flupenthixol group there was additionally a noticeable and highly
significant reduction in symptom severity after only 1 week of treatment.
Patients treated with flupenthixol had fewer and milder side-effects.

Publication Types:
Clinical Trial
Comparative Study
Multicenter Study
Randomized Controlled Trial

PMID: 2692973 [PubMed - indexed for MEDLINE]

13: Pharmatherapeutica. 1989;5(5):292-7.

Flupenthixol and fluvoxamine in mild to moderate depression: a comparison in
general practice.


Hamilton BA, Jones PG, Hoda AN, Keane PM, Majid I, Zaidi SI.

Seventy-two depressed patients attending general practices were randomly
allocated to treatment with either flupenthixol dihydrochloride (1 to 2 mg/day)
or fluvoxamine maleate (100 to 200 mg/day) to assess efficacy and side-effects
over a 4-week period. Clinical assessments were carried out before medication
(Day 1) and on Days 8, 15 and 29 of treatment using the Hamilton Rating Scale
for Depression, Clinical Global Impressions (CGI) and a patient self-assessment
visual analogue scale for depression. Unwanted symptoms were also recorded.
Reduction in mean total scores on the Hamilton scale at each assessment and
therapeutic effect improvement on the CGI were greater for patients treated with
flupenthixol (p less than 0.05). Reduction in unwanted symptoms was progressive
in both groups, but more pronounced in patients receiving flupenthixol. Twice as
many new symptoms arose in the fluvoxamine group compared to the flupenthixol
group. Four patients were withdrawn in the fluvoxamine group due to untoward
drug effects compared with none in the flupenthixol group.

Publication Types:
Clinical Trial
Comparative Study
Randomized Controlled Trial

PMID: 2501801 [PubMed - indexed for MEDLINE]

14: Acta Psychiatr Belg. 1987 May-Jun;87(3):260-6.

The psychopharmacology of borderline personality disorders.

Montgomery SA.

St Mary's Hospital Medical School, Academic Department of Psychiatry, London,
Great-Britain.

DSM-III borderline personality disorder defines a group of patients who are
characterised by impulsivity and unpredictable behaviour, inappropriate
aggression, intense and unstable relationships and are often associated with
repeated suicidal behaviour. A substantial body of research has established an
association between disturbance of serotonin and also dopamine and suicidal
behaviour in depression. A similar relationship is also seen in studies of
personality disorders which suggests the association is not specific to
depression. A placebo controlled study of low dose flupenthixol has been shown
to significantly reduce subsequent suicidal behaviour in patients with
personality disorders without depression or schizophrenia. Evidence points to a
biological basis for suicidal behaviour and borderline personality disorder and
possibly of pharmacotherapy.

PMID: 3673629 [PubMed - indexed for MEDLINE]

15: Pharmatherapeutica. 1986;4(9):561-70.

Neurotic depression accompanied by somatic symptoms: a double-blind comparison
of flupenthixol and diazepam in general practice.


Grillage M.

A total of 192 patients suffering from mild to moderate depression, with or
without anxiety, accompanied by one or more specific somatic symptoms, was
entered into a double-blind, multi-centre trial to compare flupenthixol and
diazepam as treatments for psychosomatic syndromes in general practice. Each
patient was treated for 4 weeks and assessed after 1, 2 and 4 weeks on the
Hamilton Depression Scale, with visual analogue scales of depression and somatic
symptoms, by global assessments (psychological and somatic symptoms) and on a
side-effects scale. The principal somatic symptoms were tension headache (69
patients), epigastric discomfort (59 patients), chest pain (39 patients) and
backache (25 patients). There were 9 drop-outs (2 on flupenthixol and 7 on
diazepam), of whom 5 (2 on flupenthixol and 3 on diazepam) who were treated for
at least 2 weeks were included in the analysis of results. All patients received
1 tablet a day (0.5 mg flupenthixol or 2.5 mg diazepam) for the first week.
Thereafter, all except 5 patients (3 on flupenthixol and 2 on diazepam) had
their dose doubled for the remaining 3 weeks of study. Both drugs were effective
in producing consistent improvement in all four somatic symptom groups in terms
of both depression and somatic symptoms over the 4 weeks of study. There was a
trend throughout in favour of flupenthixol as the more therapeutically
effective. Flupenthixol was significantly more effective in relieving depressive
symptoms and somatic symptoms in all four somatic symptom groups considered
together. It was also superior to diazepam as measured by its effect on the
depression sub-scales, anxiety, agitated depression, retarded depression and
melancholia. Both drugs were well tolerated, although diazepam-treated patients
showed a moderate increase in side-effects scores initially, while the scores in
patients treated with flupenthixol decreased consistently over all 4 weeks of
the trial. It is concluded from this study that flupenthixol has an important
place in the management of patients with psychosomatic illness.

Publication Types:
Clinical Trial
Comparative Study
Controlled Clinical Trial
Randomized Controlled Trial

PMID: 3763651 [PubMed - indexed for MEDLINE]

16: Pharmatherapeutica. 1986;4(7):405-10.

A double-blind comparison of once-daily flupenthixol and mianserin in depressed
hospital out-patients.


Majid I.

A double-blind, parallel group study was carried out in 51 mild to moderately
depressed hospital out-patients to assess the therapeutic efficacy and
side-effects of once-daily flupenthixol (1 mg) administered in the morning
compared with once-daily mianserin (30 mg) administered in the evening. Patients
were treated over a period of 6 weeks and assessments were made before and
during treatment using the Newcastle Rating Scale, the Clinical Global
Impression, the Hamilton Depression Scale, the Leeds Self-Rating Scale for
Depression, and a check-list of side-effects. The results showed that 91% of
flupenthixol patients and 80% of mianserin patients were assessed as 'normal' on
completion of the study period. Depressive symptoms decreased progressively in
both groups. Reports of side-effects in both groups showed a progressive
reduction in number and severity during the study. The reduction at the end of
the first week of treatment with mianserin was not as great as that seen with
flupenthixol; reports of drowsiness accounted for most of the difference.

Publication Types:
Clinical Trial
Comparative Study
Controlled Clinical Trial
Randomized Controlled Trial

PMID: 3515368 [PubMed - indexed for MEDLINE]

17: J Int Med Res. 1984;12(1):17-22.

Therapeutic efficacy of flupenthixol decanoate in schizoaffective disorder: a
clinical evaluation.


Singh AN.

The present open study was undertaken to evaluate the therapeutic efficacy and
side-effects of flupenthixol, a thioxanthene derivative in the treatment of
schizoaffective psychosis. A total of twenty in-patients, selected according to
specific research criteria were treated with flupenthixol (20 mg to 60 mg i.m.
q.2.weeks) for a period of 6 months. During the course of the study, a detailed
battery of psychiatric rating scales was completed prior to the commencement of
the treatment and at regular intervals thereafter. Additionally, detailed
physical examinations and laboratory tests were also carried out at regular
intervals. Results show that fifteen patients improved significantly, two
patients remained unchanged while three patients deteriorated and were
discontinued. Adverse effects were minimal and limited to tremor and akathisia.
The present study highlights the usefulness of flupenthixol as a monotherapy in
the management of schizoaffective psychosis.

PMID: 6692965 [PubMed - indexed for MEDLINE]

18: J Clin Psychiatry. 1983 Oct;44(10):369-71.

Depressive symptoms in chronic schizophrenic patients after withdrawal of
long-acting neuroleptics.


Wistedt B, Palmstierna T.

A double-blind randomized investigation compared withdrawal (placebo) with
continued use of long-acting neuroleptics (fluphenazine decanoate or
flupenthixol decanoate) in 41 chronic schizophrenic outpatients. After 6 weeks
there was a tendency toward higher depressive scores in the placebo group, a
difference which became statistically significant (p less than .05) at week 24.
These results do not support earlier observations that neuroleptic drugs cause
depression. Further analyses of the data indicated that depressive
symptomatology could be an early sign of relapse.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 6643398 [PubMed - indexed for MEDLINE]

19: Acta Psychiatr Scand. 1983 Jun;67(6):378-88.

Comparative double-blind study of flupenthixol decanoate and fluphenazine
decanoate in the treatment of patients relapsing in a schizophrenic
symptomatology.


Wistedt B, Ranta J.

Thirty-two chronic schizophrenics who had relapsed entered a double-blind
randomised study and were followed-up for 2 years with the intention of
measuring any difference in therapeutic effect and side effects between
flupenthixol decanoate and fluphenazine decanoate. No differences could be seen
as regards the global effect or the effect on the schizophrenic symptomatology
during the first 6 months. After 1 year of treatment flupenthixol decanoate
showed a trend towards a better effect on schizophrenic symptomatology. A
corresponding result was seen for the depressive symptoms. There were no
differences in the appearance of side effects. The need for additional
neuroleptics in the initial phase seemed to be identical for both drugs. A
possible slow antipsychotic effect with flupenthixol decanoate is probably due
to the administered dose being somewhat low (in the present study approximately
31 mg flupenthixol corresponding to 27 mg fluphenazine). This suggests that
flupenthixol should have been given in a somewhat higher dose (25 mg
fluphenazine decanoate corresponding to 40 mg flupenthixol decanoate).

Publication Types:
Clinical Trial
Comparative Study
Randomized Controlled Trial

PMID: 6349256 [PubMed - indexed for MEDLINE]

20: Acta Psychiatr Scand. 1983 May;67(5):339-52.

The discontinuance of maintenance neuroleptic therapy in chronic schizophrenic
patients: drug and social consequences.


Johnson DA, Pasterski G, Ludlow JM, Street K, Taylor RD.

In a prospective follow-up the outcome of 60 chronic schizophrenic patients who
discontinued neuroleptic therapy after remaining stable 12-48 months was
compared with controls continuing medication. Not only did the drug-discontinued
patients have more relapses (P less than 0.001), but the form of relapse was
both more severe and acute, resulting in differences of self-injury (P less than
0.05), anti-social behaviour (P less than 0.01), inpatient admissions (P less
than 0.001), and the use of compulsory powers (P less than 0.01). In patients
who relapsed, both social and work function was affected adversely for some
months. Patients who remained relapse-free without drugs (20%) had a level of
work and social function similar to medicated patients. At the end of 18 months
the patients who discontinued depot maintenance therapy were found to have been
prescribed one-third more neuroleptic drugs than controls, with a possible
increase in the risk of long-term tardive dyskinesia.

PMID: 6135298 [PubMed - indexed for MEDLINE]

21: Pharmatherapeutica. 1983;3(5):354-64.

Flupenthixol versus haloperidol in acute psychosis.

Parent M, Toussaint C.

Forty acutely psychotic patients were treated either with flupenthixol drops or
haloperidol drops in an open, 28-day controlled study. The flupenthixol group
comprised 11 schizophrenic, 8 manic, and 1 paranoid patient and there were 10
schizophrenic, 5 manic, and 5 paranoid patients in the haloperidol group. Mean
daily dosage was approximately 112 mg flupenthixol and 18 mg haloperidol.
Clinically, both drugs showed an antipsychotic effect. In the schizophrenic
patients there was a definite trend towards a more rapid relief of the psychotic
symptoms after flupenthixol treatment. In contrast to haloperidol, flupenthixol
showed a mood elevating effect and an effect on the negative symptoms, e.g.
emotional withdrawal, motor retardation, blunted affect, and disorientation.
With both drugs, the most troublesome side-effects were extrapyramidal in
nature. Initially, they were more common in the flupenthixol group: later the
incidence was similar.

Publication Types:
Clinical Trial
Controlled Clinical Trial

PMID: 6844372 [PubMed - indexed for MEDLINE]

22: Neuropsychobiology. 1983;10(2-3):131-6.

Depression-inducing and antidepressive effects of neuroleptics. Experiences with
flupenthixol and flupenthixol decanoate.


Poldinger W, Sieberns S.

The antidepressive and anxiolytic efficacy of flupenthixol has been investigated
in numerous controlled and open trials involving patients with endogenous,
reactive as well as senile depressions. When administered at a mean daily single
or multiple dose of 1-2 mg, flupenthixol proved to be a very effective and
well-tolerated antidepressant. As opposed to some of the currently available
antidepressants, flupenthixol has a rapid onset of action which is often
displayed within the first 2-3 days following its application. Flupenthixol
decanoate has also a pronounced antidepressive and anxiolytic effect which
appears to be adequate enough for treating mild to moderately severe syndromes
of depression. This depot neuroleptic has been given at a fortnightly dosage
ranging between 2.5 and 30 mg. However, if the aspect of efficacy in relation to
tolerance has to be taken in to consideration, then 5 mg are apt to be an
appropriate dose. Patients with an agitated depression and/or suicide ideation
should, however, be excluded from therapy with this drug. Extrapyramidal
movement disorders which may appear during treatment are a disadvantage of this
medication. Apparently such disorders are rarely encountered if the dose is kept
below 10 mg. Other untoward effects are very seldom indeed. A final and
conclusive judgement on the possible application of flupenthixol decanoate in
the prophylaxis of phases in patients with bipolar and periodical depressions is
as yet not feasible. Further clinical trials are necessary before flupenthixol
decanoate can be classified as a possible 'depot antidepressant'.

Publication Types:
Comparative Study

PMID: 6674820 [PubMed - indexed for MEDLINE]

23: Br J Psychiatry. 1982 Mar;140:287-91.

A controlled comparison of flupenthixol decanoate injections and oral
amitriptyline in depressed out-patients.


Tam W, Young JP, John G, Lader MH.

Sixty-eight depressed out-patients were allocated to treatment with either oral
amitriptyline (75-225 mg/day) or intramuscular flupenthixol decanoate (10-30 mg
every 14 days) in flexible dosage for 12 weeks under double-blind procedures.
Various observer- and self-rating scales were applied before and after 2, 4, 8
and 12 weeks of treatment. Twenty-four patients completed the course of
amitriptyline and 20 the course of flupenthixol. All variables improved over
time, but there were no significant differences between the two drugs. The
Newcastle scores pre-treatment were not related to drug response suggesting that
both drugs were similarly effective across a wide spectrum of depressive
disorders. Patients on amitriptyline tended to complain of dry mouth; those on
flupenthixol had a higher incidence of extrapyramidal signs, the majority
receiving anti-parkinsonian drugs at some time during the treatment.
Flupenthixol decanoate in low dose is a useful anti-depressant, but should be
restricted to short courses of treatment, to patients refractory to other
treatments, and to patients suspected of poor compliance.

Publication Types:
Clinical Trial
Controlled Clinical Trial

PMID: 7093597 [PubMed - indexed for MEDLINE]

24: Acta Psychiatr Belg. 1982;82(6):617-31.

[Flupenthixol versus haloperidol in acute psychotic episodes]

[Article in French]

Parent M, Toussaint C.

The aim of this study is to evaluate the activity of flupentixol oral high
concentration and to define the profile of the drug according to the
administered dose. The trial includes 40 acute patients (21 schizophrenics, 13
manic patients and 6 other psychotics). The study was open, but the patients
were treated at random either by haloperidol or by flupentixol. Both substances
showed a strong antipsychotic and antimanic effect. The differences according to
the administered doses were: a quicker onset of action for flupentixol in
schizophrenic patients; a more pronounced activity of flupentixol in the same
patients, as far as anxiety, depressive tendencies and defect symptoms are
concerned. Extrapyramidal side effects are the most common ones amongst the two
drugs.

Publication Types:
Clinical Trial
Comparative Study
English Abstract
Randomized Controlled Trial

PMID: 7183131 [PubMed - indexed for MEDLINE]

25: Acta Psychiatr Scand. 1981 Sep;64(3):226-37.

Flupenthixol decanoate in recurrent manic-depressive illness. A comparison with
lithium.


Ahlfors UG, Baastrup PC, Dencker SJ, Elgen K, Lingjaerde O, Pedersen V, Schou M,
Aaskoven O.

The hypothesis that flupenthixol decanoate may serve as an alternative to
prophylactically administered lithium in recurrent manic-depressive illness,
bipolar and unipolar type, was tested in two groups of patients. In Group I the
patients were allocated randomly to maintenance treatment with either lithium or
flupenthixol decanoate. The patients in Group II had previously been given
lithium and were switched to flupenthixol decanoate because of unsatisfactory
prophylactic effect of lithium, doubtful tablet compliance, troublesome side
effects, or fear of later harmful effects. The flupenthixol decanoate dosage was
20 mg every 2-3 weeks. The study was not blind. In Group I neither lithium
treatment (14 patients) nor treatment with flupenthixol decanoate (19 patients)
led to a significant fall of mean episode frequency or mean per cent time ill.
The reasons for this lack of response are not clear, but prognostically negative
selection of the patients presumably took place before and possibly also during
the hospitalization. Since absent effects cannot be compared, this part of the
trial remains inconclusive. In Group II (93 patients) treatment with
flupenthixol decanoate was associated with significant falls of the frequency of
manic episodes and per cent time ill in mania and with significant rises of the
frequency of depressive episodes and per cent time ill in depression. Increase
of depressive morbidity was seen only in patients who had been given lithium
during the pre-trial period and was presumably a result of the discontinuation
of lithium. It is not known whether flupenthixol decanoate is of value in the
prophylactic treatment of recurrent manic-depressive illness, but the drug may
be worth trying in patients whose disease is dominated more by manic than by
depressive recurrences and who do not respond to lithium or do not tolerate it
or do not take it.

Publication Types:
Clinical Trial
Comparative Study
Randomized Controlled Trial

PMID: 7324992 [PubMed - indexed for MEDLINE]

26: Acta Psychiatr Scand. 1981 Jul;64(1):65-84.

A depot neuroleptic withdrawal study. A controlled study of the clinical effects
of the withdrawal of depot fluphenazine decanoate and depot flupenthixol
decanoate in chronic schizophrenic patients.


Wistedt B.

A double-blind withdrawal trial in 41 chronic schizophrenic outpatients on
neuroleptics was carried out during 6 months. Long-acting neuroleptics
(fluphenazine decanoate or flupenthixol decanoate) were used in comparison with
placebo to determine the value in maintenance therapy. Most patients had a
rather low maintenance dose, about 12.5-25 mg fluphenazine decanoate or 20-40 mg
flupenthixol decanoate every third week. Relapse was often characterized by a
return of the dame symptoms as the patient had during his first schizophrenic
attack. Drugs were significantly more effective than placebo in preventing
relapse and readmission to hospital. 62% relapsed in the placebo groups as
compared with 27% in the drug group. All patients on active substance and
without relapse during the controlled study had their treatment discontinued for
24 months in an open follow-up investigation. This resulted in relapse of all
patients but one, i.e. a final relapse frequency of 97%. A significant weight
decrease was observed in the placebo group. The risk of withdrawal is discussed.

Publication Types:
Clinical Trial

PMID: 7032224 [PubMed - indexed for MEDLINE]

27: Curr Med Res Opin. 1981;7(8):543-9.

Once daily flupenthixol in the treatment of elderly depressed patients: a
multi-centre trial in general practice.


Valle-Jones JC, Swarbrick DJ.

Ninety-five elderly depressed patients were entered into an open trial of 0.5 to
1.0 mg flupenthixol dihydrochloride, as a single daily dose in the morning.
Eighty-seven patients were treated and assessed for 14 days, 6 patients failed
to attend follow-up appointments and 2 patients were withdrawn from the trial
because of acute physical illness. After 14-days' treatment, a decrease in the
severity of the illness was recorded on the Clinical Global Impression Scale in
77% of the patients, and statistically significant improvements were noted in
the 5 individually rated symptoms of lowered mood, fatigue, tendency to weep,
feelings of inadequacy and irritability. The number and severity of adverse
effects recorded on a check-list decreased during the treatment period. The
results suggest that flupenthixol is an effective antidepressant and is well
tolerated by the elderly as a single daily dose.

Publication Types:
Clinical Trial

PMID: 7030638 [PubMed - indexed for MEDLINE]

28: Br J Psychiatry. 1979 Dec;135:515-23.

Depressive and extrapyramidal symptoms and clinical effects: a trial of
fluphenazine versus flupenthixol in maintenance of schizophrenic out-patients.


Knights A, Okasha MS, Salih MA, Hirsch SR.

Fifty-seven patients with a diagnosis of schizophrenia were started on either
fluphenazine decanoate or flupenthixol decanoate injections in a double-blind
trial just prior to discharge into the community. During the six month follow-up
30 per cent dropped out of the treatment. Of those observed for six months, 7
per cent relapsed, 54 per cent experienced depressive symptoms and 88 per cent
extrapyramidial side-effects. Analysis of both clinical data and the ratings
failed to discriminate between the two drugs.

Publication Types:
Clinical Trial
Comparative Study
Controlled Clinical Trial

PMID: 394794 [PubMed - indexed for MEDLINE]

29: Acta Psychiatr Scand. 1979 Oct;60(4):313-22.

A double-blind comparison of flupenthixol decanoate and fluphenazine decanoate
in the treatment of chronic schizophrenia.


Pinto R, Bannerjee A, Ghosh N.

Sixty-four chronic stabilised schizophrenics were studied for 18 months in order
to assess the possible difference in therapeutic effects and side effects
between flupenthixol decanoate and fluphenazine decanoate. Although certain
differences in the BPRS sub-scores in favour of flupenthixol were present at
various stages in the study, there was no significant difference between the two
drugs in the overall antipsychotic scores at the end of the assessment period;
however, more patients on fluphenating required additional therpay for
depression or anxiety during the trial period.

Publication Types:
Clinical Trial
Comparative Study
Controlled Clinical Trial

PMID: 390972 [PubMed - indexed for MEDLINE]

30: Br J Psychiatry. 1979 Aug;135:175-9.

High dose flupenthixol decanoate in chronic schizophrenia.

McCreadie RG, Flanagan WL, McKnight J, Jorgensen A.

In a double-blind trial, female 'drug-resistant' chronic schizophrenic
in-patients were given high dose or standard dose flupenthixol decanoate for 13
weeks. Plasma flupenthixol levels showed a five-fold interindividual variation,
but were consistently higher with the high dose. Analysis of final scores showed
no statistically significant differences between groups with regards to mental
state, ward behaviour and extrapyramidal side-effects. When compared with
pre-trial scores, the extrapyramidal side-effects worsened significantly in the
high dose patients and social withdrawal decreased in the standard dose
patients. The mental state of a sub-group of patients, possibly drug resistant
for pharmacokinetic reasons, improved significantly on the high dose over the 13
weeks.

Publication Types:
Clinical Trial
Controlled Clinical Trial

PMID: 387151 [PubMed - indexed for MEDLINE]

Phil Long M.D.
Administrator
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warbird
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